1. Field of the Invention
The present invention relates to packaging for the delivery of sterile implants, for example, mammary prostheses, in a manner to facilitate handling in the operating room.
2. Description of Related Art
Currently, packaging for sterile implants, and, in particular, mammary prostheses, involves an inner sterile tray and cover for containing the sterile implant and an outer tray and cover that are sterile on the inside and non-sterile on the outside. Together, the trays and prosthesis may be packaged in a non-sterile cardboard box. In the operating room, one nurse removes the trays from the cardboard box, carefully removes the cover from the outer tray without touching the inner tray, and inverts the outer tray to drop the sterile contents onto a sterile surface which may be the hands of a scrub nurse. Alternatively, one nurse holds the opened outer tray steady while a scrub nurse reaches in very carefully to avoid contaminating her hands to remove the sterile inner tray. The scrub nurse then removes the cover over the prosthesis making it available to the surgeon.
The trays in existing packaging systems tend to be made of flexible polycarbonate with a smooth surface that can be slippery. A precision grip of current outer trays is not easy and secure because the bottoms tend to be too large relative to the span of the hand of an average nurse and the sides slope away from the bottom. In addition, any indentations or projections on the bottom or sides of current outer trays are not of appropriate orientation and/or of sufficient length, for example, only ¼ to ⅜ inch, and/or of sufficient width relative to the long axis of the digits for the tips of the thumb and at least one finger to maintain a secure grip on the tray. This configuration often makes it necessary for a nurse to hold the outer tray with both hands for stability when presenting it to the scrub nurse to remove the inner tray. When inverting the outer tray to drop the sterile contents onto a sterile surface, the nurse often finds it necessary to hold the outer tray with both hands for stability and security so the tray does not slip and drop, contaminating the sterile surface. Also, existing packaging systems do not provide a configuration that allows the nurse to easily and securely grip the outer tray with one hand while removing the sealing cover with the other hand or to easily and securely grip the outer tray with one hand while inverting it to drop the sterile contents onto a sterile surface.
Attempts by the nurse to improve gripping on the outer tray of existing packaging systems by squeezing and deforming it to alter its configuration are limited by the close proximity of the underlying inner tray, compression against the inner tray that could make its removal more difficult, and possible shifting of the inner tray that could result in its contamination.